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Gador S.A. - Aug. 3, 2018

Issue Date

Aug 03, 2018

Region

HQ

Category

Drug
$117.00

Gador S.A.

Contact Name

Hector Bignone

Contact Title

Operations Director

Form483 Address 1

Parque Industrial Pilar, Calle 10 No. 103

Form483 Address 2

Form483 City

Pilar, Buenos Aires

Form483 State

Form483 Postal

1629

Form483 Country

Argentina

Inspection Range

Jul 30, 2018 - Aug 03, 2018

Pages

1

First Observation

Your Quality Unit failed to effectively monitor the stability program (on-going) for ensuring that stabilily samples are evaluated within the established time frame of 30 days.
Investigator(s): Jose E. Melendez